FDA sets priority review for tuberculosis drug

NEW BRUNSWICK, N.J.
(AP)
–
Johnson & Johnson said Wednesday that the U.S. Food and Drug Administration will give a priority review to its experimental treatment for multidrug-resistant tuberculosis.

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J&J's Janssen Research & Development unit on June 29 applied for approval to market bedaquiline, or TMC207, as part of combination therapy for adults with multidrug-resistant tuberculosis lung infections.

Under a priority review, the FDA aims to decide whether to approve drugs within six months of the application's submission, rather than the standard 10 months, because they may offer a major advance or treat a condition with few or no therapies. Bedaquiline would be the first drug specifically for multidrug-resistant tuberculosis, and the first new type of TB drug in more than four decades.

About 1.4 million people worldwide die from tuberculosis each year, roughly 10% of them from forms resistant to at least two of the standard drugs for the deadly bacterial disease.

J&J applied for approval to market the drug in the European Union on Aug. 31.

In late-morning trading, J&J shares were up 26 cents at $67.52.

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